NCT02765321

Brief Summary

This is a population-based "natural experiment" study aimed to examine the effect of a multi-approach intervention focused on physical activity and healthy eating promotion to individuals living in Jaguariuna city (São Paulo, Brazil).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

May 6, 2016

Status Verified

May 1, 2016

Enrollment Period

8 months

First QC Date

May 2, 2016

Last Update Submit

May 5, 2016

Conditions

Health Behavior

Outcome Measures

Primary Outcomes (1)

  • waist circumference

    7 months

Secondary Outcomes (15)

  • fasting glycemia

    7 months

  • fasting insulinemia

    7 months

  • total cholesterol

    7 months

  • LDL-cholesterol

    7 months

  • HDL-cholesterol

    7 months

  • +10 more secondary outcomes

Study Arms (1)

Physical activity and healthy eating promotion

EXPERIMENTAL
Behavioral: Healthy lifestyle promotion

Interventions

Healthy lifestyle promotionBEHAVIORAL

Healthy lifestyle changes (i.e., increase in physical activity levels and improvement in eating habits) will be promoted via population-based counselling through media (i.e., radio, newspapers, magazines, television, banners), cell phone applicative, workshops, specific programs at schools and companies, and community physical activity programs.

Physical activity and healthy eating promotion

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • citizens from Jaguariuna city (Sao Paulo, Brazil)

You may not qualify if:

  • citizens not from Jaguariuna city (Sao Paulo, Brazil)
  • children below 8 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05508-30, Brazil

RECRUITING

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Fabiana B Benatti, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Marcio Atalla

    Casa do BemStar Marcio Atalla

    PRINCIPAL INVESTIGATOR

  • Evelyn F Costa, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Alex Florindo, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 6, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2016

Last Updated

May 6, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)